Selected category: Quality, Compliance & Regulatory

You are considering an Original Equipment Manufacturing (OEM) partner to support you in bringing your idea to market. The planned IVD device may require components, robotics and modules. You may need integration into an existing platform or the development of a completely new customized system. What else should you take into account when selecting an ideal OEM partner?

When introducing a new product to the automated liquid handling market, getting there first with high quality and reliable hardware is vital to capturing and maintaining early market leadership. How can you gain that advantage when you have to balance requirements for customized high-performance robotics against an accelerated product launch?

Rapid advances in molecular diagnostics, including the application of advanced methods such as next generation sequencing (NGS) in clinical diagnostics, are revolutionizing healthcare. But this puts a lot of pressure on clinical labs to develop, optimize, validate and gain regulatory approval of high throughput assays. The secret to successful automation in the clinical regulatory environment lies in anticipating potential pitfalls.

The repeatability of biomedical research has become a major issue, and the ability to achieve reproducible research results can only be as good as the liquid handling performance. Automation has become a given step in the drive to generate reproducible data so how well can automated liquid handling perform in, for example, genomics applications?

When designing products that include automated liquid handling, how do you decide when and what to buy from an OEM components supplier vs. designing in-house? How do you then decide who will be the right partner for you? A well-planned “make versus buy” analysis and OEM-components partnering strategy can significantly augment the expertise of your own team. It can free up internal resources for other projects, reduce long-term costs, and ultimately help get your products to market faster.

Cognitive computing and artificial intelligence have the power to save us from drowning in the vast and growing sea of data needed for precision medicine, but what will it take to achieve a timely return on investment? Experts from multiple disciplines will gather to share their perspectives on this challenging problem at the upcoming Tecan Symposium in Salt Lake City on November 14th.

In an increasingly regulated industry, clinical laboratories and manufacturers of in vitro diagnostic (IVD) tests are feeling the pressure to ensure regulatory compliance, while at the same time striving to increase productivity and bring innovative technologies on stream. At times, this balancing act can seem like a losing proposition.

Hospitals are becoming the new centers of innovation for novel clinical diagnostic tests. While this is enabling more sophisticated and personalized approaches to disease prevention, early diagnosis, and targeted treatment, it also has the potential to create major headaches for regulatory management of clinical labs.

As we have seen in the previous posts in this series, developing validated analytical methods becomes more cost- and time-effective when solutions with guaranteed compatibility are incorporated into the analytical system.

A long-term clinical lab study lasting over 10 years showed that more than 60% of all mistakes in the stat lab (the lab that receives high priority samples) can be attributed to the pre-analytical phase. This figure has not changed much from 1997 to 2007,1, 2 despite advances in the technology.

Well-documented reliable, accurate data that meets regulatory demands is crucial for success The key is to develop robust analytical methods based on instruments and other components that perform well together to ease the way forward through Installation Qualification and Operational Qualification (IQ/OQ) and method validation.

If the U.S. Food and Drug Administration (FDA) goes forward with its proposed guidance to regulate laboratory developed tests (LDTs) in the same way it does manufacturer-derived tests, then much is going to change for clinical laboratories, their industry partners that produce the reagents, assays, and instruments needed to perform these tests, and the clinicians and patients who have come to rely on LDTs to fill the gap in diagnostic testing.

Scinomix, Inc., founded in 2001, creates customized solutions for labeling tubes, vials and plates in many life science applications. We took the chance to ask Nigel Malterer (CEO) and Jonathan King (Automation Software Engineer) at Scinomix about how automated barcode labeling solutions are helping to improve productivity, reduce errors and costs, and increase control over lab workflows.

The intention by the U.S. Food and Drug Administration (FDA) to issue a new guidance that would bring oversight of laboratory developed tests (LDTs) directly under FDA regulatory control, instead of the current paradigm in which LDTs are regulated by FDA's Clinical Laboratory Improvement Amendments (CLIA), is creating much uncertainty and not a little distress. What would this significant change mean for laboratories that already rely on LDTs, are improving existing tests and actively developing new ones?

Uncertainty and concern best describe the prevailing feelings of many researchers, clinicians, and companies that develop, manufacture, and implement laboratory developed tests (LDTs). The reason for all this uncertainty is the U.S. Food and Drug Administration's (FDA) stated plan to issue a new guidance that would change the paradigm for regulating LDTs.

Whatever you are using automated liquid handling for, be it drug development, next generation sequencing, assay development or basic research with cell-based assays, getting correct results is crucial to reaching your goals, quickly and efficiently. And you also need to prove the validity of your data for regulatory compliance. The question is, how can this be achieved with little effort?

Barcodes play a central role in minimizing the risk of error in lab automation by providing secure tracking of components throughout the workflow. Barcode-guided lab automation can be simple and cost-effective, with significant paybacks thanks to productivity increases.

Robotics and automation have become essential to the future plans of drug discovery and clinical diagnostic companies. Executives are looking to increase productivity and reduce costs, and automation fits the bill in every respect.

Today there is much discussion on the Food and Drug Administration (FDA) regulation and oversight of Laboratory Developed Tests (LDTs). The debate features numerous topics including the necessity for regulation, whether the FDA has the authority to regulate, the feasibility of the proposed regulations, and the effect on innovation if indeed regulation is put into place.

Congratulations. It took you quite some time and effort to convince your management or institution on the value of investing in automating your experimental or clinical workflow. The applications were submitted, the presentations were made and the wheeling and dealing to secure the budget resulted in you and your team landing the investment. You've arrived. Now all you have to do is choose the robot and get it up and running.

By Martin Braendle

(Part 2 of 2. Read Part I). In 1948, Bill Koster of the Variety Club of New England and Dr. Sidney Farber working at the Children’s Hospital Boston had launched The Children's Cancer Research Fund, aimed at supporting a hospital dedicated to the research of childhood leukemia. But they needed a poster child to boost fundraising.

By Martin Braendle

In his book, The Emperor of All Maladies, Siddhartha Mukherjee tells the story of one of the turning points in the history of cancer medicine. A turning point that he dates to May 1947. In this two-part article we will look at how cancer research has been transformed by fundraising.